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clinical research in Raleigh

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  1. Senior Medical Writer (home based)

      Regulatory Medical Writer Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms   Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical ...

  2. Senior Project Manager

     Note: Candidates must possess Ph. 1 and 2 Full Service Oncology PM Experience ~~SUMMARY: The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines.  In-depth knowledge and experience of the drug development process is required, including study initiation, clinical ...

  3. Clinical Document Specialist

      ~~SUMMARY: • The CDS will support the Company’s regulatory function and study team in the document management of clinical research trials from the project development stage through to project completion.  Mainly, the CDS will perform a variety of research, database, and administrative duties of a routine and technical nature in support of clinical trials to assist investigators in organizing, gathering, and compiling clinical research data. DUTIES AND RESPONSIBILITIES: • Assist with collecting, ...

  4. Clinical Project Assistant

      ~~SUMMARY: The CPA will support the clinical project managers and study team in the administrative project management of clinical research trials from the project development stage through to project completion.  DUTIES AND RESPONSIBILITIES: • Provides project management support including preparation of scope documents, follow-up on project timelines and deliverables, and project participation. • Manage active study files (central files) and prepare key documents for archiving according to client ...

  5. Regulatory Affairs Specialist

    ~~SUMMARY: • The Regulatory Affairs Specialist supports the Company’s regulatory function and project teams through the provision of a variety of administrative and technical tasks involving the management of clinical research trials documentation. In addition, the Regulatory Affairs Specialist performs a variety of research, database, and administrative duties of a routine and technical nature in support of corporate initiatives and clinical trials to assist MedSource and/or clients in organizing, ...

  6. $5K Sign On Bonus- CRA  Monitors Needed - Set Yourself Up for Success

    CRAs - Join Covance and receive a $5000 Sign On Bonus! Meet the CRA hiring team at the ACRP conference - email [email removed].   Set yourself up for SUCCESS with Early Clinical Development! Now is the time to join our growing business where you have supportive management and a cohesive team. At Covance, you are not just a number. We value you and your hard work...we want you to succeed.   URGENT Need for Oncology Monitors!  Calling all Experienced Clinical Research Associates / CRAs / ...

  7. Postdoctoral Research Associate

      Postdoctoral Research Associate Application 3C Institute is a growing research and development company in Cary, NC, that creates and delivers evidence-based programs and web-based applications to promote health and wellbeing. Individuals who have recently earned their doctorate degrees are invited to apply for a unique postdoctoral position combining cutting-edge, evidence-based project work with development, implementation, and dissemination of high quality research. If selected for this ...

  8. Clinical Project Manager (Global/Oncology)

    Global PM Desired Skills & Experience •          College/University degree in life sciences, RN preferred •          At least 5 years of prior industry experience •          At least 2 years of experience at a position of Clinical Project Manager •          Previous CRO experience required •          Therapeutic experience - Oncology. •          Participation in at least three clinical research projects in the capacity of a Clinical Project Manager •          Proficiency in standard MS Office ...

  9. Medical Affairs Consultant

    Brio Resource Group is seeking a Medical Affairs Consultant to perform medical review for an open ended contract with an emerging Pharmaceutical company supporting their Promotional Review Committee (PRC) by providing medical and scientific input to ensure the accuracy of promotional materials. Responsibilities include developing and reviewing abstracts, manuscripts, posters and slides for scientific meetings for company products.  Participate in routine Promotional Review Committee Meetings. ...

  10. Quality Assurance Manager GCP/GMP Operations

    Brio Resource Group is seeking a Quality Assurance Manager GCP/GMP Operations for an emerging pharmaceutical company located in the Raleigh/Durham, NC area. The QA Manager will be responsible for Clinical Trial Development projects and additional Quality Assurance Manufacturing activities.  Job Requirements: -Responsible for Clinical Supplies batch record review providing final release for use in clinical trials -Quality Assurance contact for deviations and failures -Clinical vendor selection ...

  11. Senior Clinical Research Associate

    We are currently looking to hire Permanent Regional CRAs Job Description   The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, ...

  12. Research Associate and Senior Researchers

                                                                        Research Position Openings                                                          Tired of having your research just sit on a shelf?                                        3C transforms research into practical, professional applications for real-life use.                                      We at 3C are building a tangible bridge over the research-practice gap, slat by slat.                                                     ...

  13. Research Assistant

                                                                    Research Position Openings                                                    Tired of having your research just sit on a shelf?                           3C Institute transforms research into practical, professional applications for real-life use.                            We at 3C are building a tangible bridge over the research-practice gap, slat by slat.                                                       Would you like to ...

  14. Laboratory Technical Specialist

    Laboratory Technical Specialist Tracking Code 1215 Job Description Our company is looking for an experienced Laboratory Technical Specialist to perform BSI database, lab quality assurance, and DNA activities. Duties include: Client Interactions In conjunction with the study staff, lab director, and senior laboratory technical specialist, communicate directly in a professional manner with clients such as the National Institute of Environmental Health Sciences (NIEHS). Communicate in a professional ...

  15. Biostatistician

    Biostatistician Tracking Code 1185 Job Description Our company is seeking a Biostatistician to support population-based and clinical research studies through contracts with the National Institutes of Health (NIH) and National Institutes of Environmental Health Sciences (NIEHS), the Centers for Disease Control and Prevention (CDC), Veterans Affairs (VA), and other governmental agencies. As a Biostatistician in our group you will have the opportunity to participate in interesting health research ...